Clinical Trials Information for Participants
Building a better community means providing access to research trials that improve the quality of our health care.
You have the option to participate in any one of our numerous active clinical trials for which you meet the study qualifications. Below are some frequently asked questions regarding the Clinical Trials process, including safety, benefits, and more.
Clinical Trials: Frequently Asked Questions
Clinical trials are research studies used to look at new ways to treat, prevent, or detect diseases. The data collected helps us understand potential side effects, interactions with other medications, and the effectiveness of the investigational product. Clinical trials are highly regulated with strict safety and ethical guidelines.
When volunteers take part in clinical research, they help researchers and physicians learn more about medical conditions and treatments and improve outcomes for people in the future.
Clinical trials can be observational or interventional. Observational trials collect information and usually require minimal time and few, if any, research related procedures. In interventional trials, the participant is receiving some kind of treatment and usually require more research related visits and procedures. Each trial is different. Study related procedures might include physical exams, questionnaires, bloodwork, and ECGs.
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. Individual participants' names will remain confidential.
All research study related office visits, procedures, tests, and treatment are free of charge and do not require use of your medical insurance. You may however be billed for routine care that you would normally receive from your physician.
Participants can gain access to new drugs, devices, and other treatments before they are widely available, and you would be helping others by contributing to medical research.
Possible risks will vary for each specific trial and can range from minor risks to major risks. Risks and side effects are always disclosed and thoroughly explained in an informed consent document provided to you before you agree to participate. The Principal Investigator or study coordinator will explain the possible risks or side effects. You are given adequate time to review the consent form and ask questions of the research staff, physician, or any other specialists or family members you wish to consult.
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, investigational treatments are often compared with placebos to assess the investigational treatment's effectiveness.
All research studies are completely voluntary, and you may withdraw at any time. The Principal Investigator can withdraw you from the study if new potential risks are reported. We ask that you communicate with our study staff so we can ensure you are withdrawn from the study safely.
Informed Consent
Informed Consent is a process of providing you with key information about a research study. This process will help you decide whether to take part. This process will continue throughout the study. The research team will explain the details of the study and provide you with the signed informed consent document. This document will include the details about the study, such as the purpose, how long it’s expected to last, tests, and procedures that will be done as part of the research study. Risks and benefits are also explained in the informed consent. Taking part in a clinical trial is voluntary and you can leave the study at any time. If you have any questions and/or concerns, the research team will be available to respond.
Volunteering for Research
If you are a research participant currently participating in a clinical trial and have questions, please contact the investigator listed on the front page of your informed consent form.
If you have general questions about clinical trials, please contact us at ResearchReview@virtua.org.
Phases of Clinical Trials
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
Phase I
In Phase I trials, researchers test an investigational study drug or treatment in a small group of people (approx. 20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II
In Phase II trials, the investigational study drug or treatment is given to a larger group of people (approx.100-300) to see if it is effective and to further evaluate its safety.
Phase III
In Phase III trials, the investigational study drug or treatment is given to large groups of people (approx. 1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
Phase IV
In Phase IV trials, post marketing studies define additional information including the drug's risks, benefits, and optimal use.